Director, Clinical Quality Program Lead (Biotech)

TL;DR

Director, Clinical Quality Program Lead (Biotech): Overseeing quality strategy and inspection readiness across clinical trial programs with an accent on risk-based quality management and GCP compliance. Focus on leading cross-functional teams, implementing Quality by Design principles, and ensuring robust governance models for clinical development.

Location: Must be based in or able to commute to Boston, MA (Hybrid)

Company

hirify.global is a global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Partner with clinical operations and regulatory stakeholders to align quality strategies and ensure real-time inspection readiness.
• Identify quality risks proactively and implement effective mitigation and contingency plans.
• Provide leadership and guidance on risk-based quality approaches, including Quality by Design principles.
• Oversee the quality of clinical trials within assigned disease areas to ensure compliance with ICH-GCP and international regulations.
• Manage departmental resources, including hiring, training, performance management, and career development for the team.
• Contribute to the strategic evolution of Global Clinical Quality processes and governance models.

Requirements

• 10+ years of relevant work experience in a GCP quality oversight role.
• Proven line management or supervisory experience.
• Deep understanding of ICH-GCP guidelines and international clinical trial regulations (e.g., US Title 21 CFR, EU CTR).
• Demonstrated experience in applying risk-based quality principles in a pharmaceutical environment.
• Strong analytical, problem-solving, and critical thinking skills.
• Ability to travel up to 10% to vendor and investigator sites.

Nice to have

• Professional clinical trial certification (e.g., CCRP, RQAP-GCP).

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Educational assistance programs, including student loan repayment.
• 401(k) retirement plan with company matching.
• Commuting subsidy and charitable donation matching.
• Flexible hybrid work environment.